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12 May 2012

Three Member Committee Constituted to Examine Drug Approval Procedures

Taking note of the 59th Report of the Parliamentary Standing Committee on the functioning of the Central Drugs Standard Control Organization (CDSCO), the Union Minister of Health and Family Welfare Shri Ghulam Nabi Azad has constituted a committee of three experts comprising Dr. V M Katoch, Secretary and DG, ICMR, Dr.P.N Tandon, President, National Brain Research Centre, Department of Biotechnology, Manesar and Dr S S Aggarwal, former Director, Sanjay Gandhi Postgraduate Institute of Medical Sciences, Lucknow.

The Committee has been asked to:

(i) examine the validity of the scientific and statutory basis adopted for approval of new drugs without clinical trials.

(ii) outline appropriate measures to bring about systemic improvements in the processing and grant of statutory approvals.

(iii) suggest steps to institutionalise improvements in other procedural aspects of functioning of the CDSCO.

The Committee has been asked to submit its report within a period of two months.

The Parliamentary Standing Committee Report has, inter alia, made recommendations and observations on various aspects such as organisational structure and strength of CDSCO, approval of new drugs, banning of drugs, approval of fixed dose combinations, pharmacovigilance, spurious / sub-standard drugs, etc. The Report has also pointed out certain irregularities particularly in the area of approval of new drugs without clinical trials.